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Catalog Number 0113120 |
Device Problems
Mechanical Problem (1384); Failure to Form Staple (2579)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2022 |
Event Type
malfunction
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Event Description
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As reported, during a ventral hernia repair procedure on (b)(6) 2022, the patient was implanted with an unknown mesh fixated using a bard/davol permafix fixation device.As reported, counter pressure was applied on the target area while fixating the implant into the tissue and the handle (trigger) was able to be pulled completely.It was reported that the fastener has no firing force and the mesh cannot be fixated into the tissue.It was reported that fasteners were loose and removed from the patient body.There was no reported patient injury.
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Manufacturer Narrative
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As reported, the permafix fixation device didn't fixate the mesh.There was no reported patient injury.At this time the sample has not been provided for review.A video of the device was provided and evaluated.Review of the video provided shows an unknown user actuating the device outside of an or setting onto a table top.The user is slowly pulling on the trigger and deploying a fastener with no issue.However, during the dry deployment it was shown that the user was not using a complete and continuous stroke in the video to deploy as per the ifu.Based on the information provided and investigation performed, the root cause of the reported event cannot be determined.The instructions-for-use (ifu) for the permafix fixation device prescribes the proper method for use of this device for proper fastener delivery and includes "place the tip of the permafix fixation system at the desired location perpendicular (90 degree angle) to the mesh or tissue and apply adequate pressure.Different types of mesh may require different amounts of counterpressure.Adjust angle and counterpressure appropriately." if/when sample is received and evaluated, a supplemental mdr will be submitted.Note, the date of event is provided as a best estimate (b)(6) 2022) based on the reported event.Not returned.
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Search Alerts/Recalls
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